FDA approves RSV vaccine


After a 60-year scientific quest, the world has its first vaccine to protect against respiratory syncytial virus, or RSV – and more are on the way.

On Wednesday, the US Food and Drug Administration approved Arexvy, made by GSK, which is designed to be given as a single shot to adults 60 and older.

It could be available for seniors as soon as this fall, pending a recommendation for its use from the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, which next meets in June.

“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement. “Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States.”

Although RSV is a disease that’s often associated with babies and young children, it can also be dangerous for seniors. In the US, an estimated 159,000 adults 65 and older are hospitalized each year with RSV, and an estimated 10,000 to 13,000 die as a result of their infection.

“RSV certainly is an important disease in the elderly. In some years, the burden of RSV disease comes close to the burden of flu in the elderly. And this is really a wonderful development,” said Dr. Ruth Karron, a professor of international health at Johns Hopkins Bloomberg School of Public Health, who was not involved in the development of the vaccine.


Three other RSV vaccines for older adults are also in the final phases of testing.

The FDA is expected to make a decision on Pfizer’s RSV vaccine for older adults by the end of May. The agency is also reviewing Pfizer’s maternal vaccine to protect infants and is expected to make a call on that one by the end of August.

Moderna is finishing its Phase 3 trial of an mRNA vaccine for RSV in older adults and expects to submit the results to the FDA for approval within the next few months.

Bavarian Nordic, maker of the Jynneos mpox vaccine, says it will report results from a Phase 3 trial of its RSV vaccine for older adults this year.

Paul Chaplin, president and CEO of Bavarian Nordic, says there’s a saying in Britain that you’ll wait a long time for a bus, and then four will show up at once. The race to the finish line for an RSV vaccine is a little bit like that, he says.

“We’ve been waiting decades for a safe effective RSV vaccine, and there’s been numerous attempts that have failed,” Chaplin said.

“And I know GSK will likely get the first approval, but there are others coming through, including us. And I just think it’s fantastic, because RSV is a huge unmet medical need that a lot of people underestimate the importance of, and we will hopefully now have a number of effective vaccines that will help protect people.”

We’ve discussed RSV before, often in the context of other viruses. I’m a few years away from being in the group of people for whom this vaccine is recommended, but who knows, that could change any time. I’m glad we’ll have this option. The story of how we got to where we are, and the disastrous first attempt at an RSV vaccine in the 60s, is worth your time to read. And if you are in that group that ought to get this shot, please do yourself the favor and do it.

Related Posts:

This entry was posted in Technology, science, and math and tagged , , , , , . Bookmark the permalink.